This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Latin America. The primary countries covered will include: Argentina, Brazil and Mexico. Other countries such asChile, Costa Rica, Dominican Republic, Panama, Peru and Venezuela will be discussed. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America. Content will include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.
The current regulatory climate in Latin America is discussed in detail and several examples will be provided to illustrate effective compliance procedures and techniques. Common issues that have caused difficulties for Life Sciences firms in the region are outlined. Course content will explain how Latin America interacts with and utilizes ICH standards and how they relate with other national regulatory agencies. Additionally, participants will learn how personnel can best address the conflicts, which arise and the best course for resolution.
Agenda: (All time in EST)
1:00 – 2:15 pm Course Delivery
2:15 – 2:30 pm Q&A Session
Areas Covered in the Seminar:
• Glossary of Terms.
• Defining the Opportunity.
• Country Facts: Argentina, Brazil, Mexico.
• Latin America's Regulatory Structure for the Life Science Product Industries
• Mercosur - Southern Common Market.
• Beginning Your Company Involvement in Latin America: Examples of Country Requirements.
• Registration / Required Country Licenses.
• Common Fees.
• Overview of the Rules Governing Medicinal Products & Medical Devices.
o Drug vs. Medical Device vs. Biologic vs. Combination Product.
• Drug Master File (DMF) Use in Latin America Registrations.
• Use of Expert Reports.
• Processing Variations on Licensed Products.
o Variations: Changes to Marketed Products.
o Types of Variations.
o Dossier Maintenance Expectations.
o Changes Concerning Manufacturing Aspects (Product & Process).
• Labeling & Packaging Leaflet Requirements.
• Orphan Drugs / Rare Diseases.
• Comparing and Contrasting Latin American Procedures vs. the U.S. FDA.
o Comparison of Processes.
o Agency Interactions.
o Accepted Practices.
• How and When to Influence the Regulatory Process.
o Accepted Country Practices.
o Effective Monitoring Activity.
o Association vs. Individual Company Involvement & Intervention.
• The Regulatory Negotiation Process.
o Effective Approaches.
o The Do's and Don'ts of Regulatory Involvement.
• How to Use Regulations / Regulatory Contacts to Your Advantage.
o Check-in Procedure.
o Agency Interactions.
o Business Impact Within and Outside Latin America.
o Professionalism in Regulatory Lobbying.
• Resources / Helpful Websites
Who Will Benefit:
This course will be beneficial to:
• Regulatory personnel whose responsibilities require knowledge of the Latin American regulatory environment
• Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements
• QA / QC Personnel
• Global Supply Chain personnel
• Clinical / Pharma & Device personnel
• Manufacturing personnel
• Global Business Development personnel
• Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization
Robert J. Russell, is President and CEO of RJR Consulting, Inc, a leading Global Regulatory Consulting firm focusing on assisting the Life Science Industry. Prior to founding the firm in 2000, Mr. Russell had over 27 years of experience in CMC, Global Business Development and Regulatory Compliance for pharmaceuticals, biologics, medical devices and combination products. The company has an office in Brussels, Belgium where they interact with the European Commission and the Competent Authorities across the EU. Country establishment, marketing authorizations, variations and license renewals are core competencies of the course director. Mr. Russell has received a B.S. and M.S.in Chemistry.
10777 Westheimer Suite 1100
United States of America 77042
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